FDA May Authorize Vaccine Before Trials Finish

FDA May Authorize Vaccine Before Trials Finish

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FDA Commissioner Stephen Hahn stated that the agency might fast track a COVID-19 vaccine if deemed appropriate, granting emergency authorization before phase three trials conclude. He emphasized that this decision would be based on science, not politics, and clarified that emergency authorization differs from full approval, requiring that benefits outweigh risks in a public health emergency. The authorization could be used to vaccinate high-risk groups before trials are complete. Hahn has faced political pressure from President Trump, who accused the FDA of slowing vaccine development to affect his reelection chances.

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